OBJECTIVE:To investigate clinical efficacy and safety of Kang'ai injection adjuvant chemotherapy for advanced lung cancer. METHODS:A total of 146 patients with advanced lung cancer during May 2013-Apr. 2014 were divided into observa-tion group and control group according to odd-even admission number,with 73 cases in each group. Control group was given GP (gemcitabine+cisplatin)chemotherapy. Observation group was additionally given Kang'ai injection 60 mL added into normal saline 250 mL,qd,ivgtt,for consecutive 14 d each chemotherapy cycle,on the basis of control group. Both groups were given tropise-tron 5 mg for preventing gastrointestinal reaction during chemotherapy. A treatment course lasted for 3 weeks,and both groups were treated for 3 courses. Clinical efficacies of 2 groups were compared;the levels of serum inflammatory factors (hs-CRP, TNF-α,IFN-γ,IL-10),immune function indexes(CD3+,CD4+,CD8+,CD4+/CD8+)and tumor markers(SCC-Ag,CEA,CA50, CA72-4) were compared before and after treatment. The occurrence of ADR were recorded in 2 groups. RESULTS:The response rate and disease control rate of observation group were 39.73％ and 84.93％,which were significantly higher than 23.29％ and 71.23％ of control group,with statistical significance(P<0.05). Before treatment,there was no statistical significance in the lev-els of serum inflammatory factors,immune function indexes or tumor markers between 2 groups (P>0.05). After treatment,the levels of hs-CRP,TNF-αand IFN-γin 2 groups were significantly lower than before treatment,while the level of IL-10 was signifi-cantly higher than before treatment;above indexes of observation group were significantly better than control group,with statistical significance(P<0.05). The levels of CD4+ and CD4+/CD8+ in control group were decreased significantly and lower than observa-tion group,with statistical significance(P<0.05). Serum levels of SCC-Ag,CEA,CA50 and CA72-4 in 2 groups were decreased significantly,and observation group was significantly lower than control group,with statistical significance(P<0.05). The inci-dence of thrombocytopenia,neutropenia,abnormal liver function,nausea and vomiting,anemia in observation group were signifi-cantly lower than control group,with statistical significance(P<0.05). CONCLUSIONS:Kang'ai injection adjuvant chemothera-py can effectively relieve inflammation symptoms of patients with advanced lung cancer,reduce toxic reactions,enhance immune function, and improve short-term therapeutic efficacy with good safety.